Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02516332
Eligibility Criteria:
Inclusion Criteria:
* Men and women with documented CHD (i.e., a prior MI, coronary revascularization procedure, or \>70% stenosis in at least one coronary artery)
* Age \> 39 years
* Patients also will have an anxiety symptom severity score of at least 8 on the Hospital Anxiety and Depression-Anxiety scale (HADS-A) or a DSM-5 diagnosis of an Anxiety Disorder, such as General Anxiety, Social Anxiety, or Panic Disorder.
The study team plans to actively recruit women and minorities, with at least 50% women and 25% minorities.
Exclusion Criteria:
* An MI or coronary revascularization procedure (i.e., CABG or percutaneous coronary intervention) within the last 3 months
* Unstable angina
* Severe left ventricular dysfunction (ejection fraction \<30%) or decompensated heart failure
* Unrevascularized left main coronary artery stenosis \>50%
* Complete Pacemaker dependence
* Resting BP \>200/120 mm Hg
* Conditions that would preclude randomization to either the drug (e.g., prolonged QT interval, known allergy to or intolerance of escitalopram) or exercise (e.g., musculoskeletal problems or abnormal cardiac response to exercise)
* Patients with a primary psychiatric diagnosis other than Anxiety Disorder will be excluded, including patients with PTSD, OCD, or any of the following DSM-5 diagnoses:
1. Dementia, delirium;
2. Schizophrenia, Schizoaffective, or other psychotic disorder;
3. Psychotic features including any delusions or hallucinations; or
4. Current alcohol or other substance abuse disorder.
* Similarly, patients who pose an acute suicide or homicide risk or who, during the course of the study, would likely require treatment with additional psychopharmacologic agents will not be enrolled.
* Patients will also be excluded if they are taking other medications that would preclude assignment to either drug or exercise conditions (e.g., clonidine, dicumarol, anticonvulsants, and MAO inhibitors) or are taking herbal supplements with purported mood effects (e.g., St. John's Wort, valerian, ginkgo).
* Patients already engaged in regular exercise (at least 30 minutes \>1x/week) will not be enrolled.
* Finally, pregnant women will be excluded from participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02516332
Study Brief:
Protocol Section:
NCT02516332